Add-on Nighttime Bracing in Adolescent Idiopathic Scoliosis

Scoliosis Clinical Trial

Official title:

Retrospektive Analyse Der Konservativen Skoliosetherapie - Doppelkorsettversorgung Mittels Tag- Und Nachtorthese Versus Ganztagesorthese

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05424419
• Other study ID #: EK 27012018
• Status: Completed
• Start date: January 2, 1997
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2022
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Bracing is an accepted standard therapy for idiopathic scoliosis at Cobb angle ranges between 25° and 45°. However, it is unclear, if a specifically tailored regimen of daytime and nighttime braces (=double brace) yields superior results compared to the standard treatment (single brace for day and night). These two treatment regimens were investigated in the study.

Description:

One-hundred-fifteen patients with adolescent idiopathic scoliosis (AIS) were assessed before initiation of bracing treatment and at the final follow-up 2 years after deposition of the brace. They were divided into two groups: double-brace group and single-brace group. Each patient underwent clinical and radiological examinations and Cobb angles were measured.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 15 Years

Eligibility

Inclusion Criteria:

• AIS

• age between 10 and 15 years (y)

• Risser's sign of 0-2

• Cobb curvature angle of 25-40°

• no previous treatment

• compliance (at least 23 h wearing time)

Exclusion Criteria:

• non-idiopathic scoliosis

• Cobb curvature angle >40°

• <10 years and >15 years for initial treatment

Related Conditions & MeSH terms

• Scoliosis

Intervention

Procedure:
• Brace therapy
A Chêneau-type brace was made to be worn as a full-time brace or during daytime only (double-brace group), whereas the nighttime brace was produced according to the Charleston approach.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	primary correction	Primary correction (%) of brace therapy (Cobb angle measurement)	At study inclusion with initiation of brace therapy
Secondary	Cobb angle reduction	Follow-up Cobb angle (degree) in relation to the initial Cobb angle	2 years after deposition of the brace